Remove Containment Remove Contamination Remove Generic Drugs Remove Regulation
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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Food and Drugs Act , R.S.C.,

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

They will need to conduct crossover studies in healthy individuals who will receive the brand name and the generic drug; the plasma concentration-time profile results will then be compared to see if the two are bioequivalent. coli, where small amounts of contaminants could cause significant toxicity.

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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.

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COVID-19 Pandemic Coverage

XTalks

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months. Drugs and Vaccines. Here in Canada, retail sales dropped by 26.4 The main reason the elastomeric respirators are being so little used?